TUNGSTEN COATED EYESHIELD MT-T-45-S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-05-11 for TUNGSTEN COATED EYESHIELD MT-T-45-S manufactured by Civco.

Event Text Entries

[448942] Facility tried two eyeshields on one pt and felt it was too thick and caused a cornial abrasion.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1932738-2006-00001
• MDR Report Key: 714591
• Report Source: 05
• Date Received: 2006-05-11
• Date of Report: 2006-04-21
• Date of Event: 2006-01-11
• Date Mfgr Received: 2006-01-11
• Date Added to Maude: 2006-05-17
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Street: P.O. BOX 320 1401 8TH STREET S.E.
• Manufacturer City: ORANGE CITY IA 51041
• Manufacturer Country: US
• Manufacturer Postal: 51041
• Manufacturer Phone: 7127378688
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TUNGSTEN COATED EYESHIELD
• Generic Name: EYESHIELD
• Product Code: HOY
• Date Received: 2006-05-11
• Model Number: MT-T-45-S
• Catalog Number: MT-T-45-S
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 703656
• Manufacturer: CIVCO
• Manufacturer Address: * ORANGE CITY IA * US
• Baseline Brand Name: TUNGSTEN COATED EYESHIELD
• Baseline Generic Name: EYESHIELD
• Baseline Model No: MT-T-45-S
• Baseline Catalog No: MT-T-45-S
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2006-05-11